Studienzentrum
Willkommen auf den Seiten des klinischen Studienzentrums der Essener Universitäts-Hautklinik.
Das klinische Studienzentrum der Essener Universitäts-Hautklinik ermöglicht qualitativ hochwertige klinische Forschung, die zur Einführung neuer Medikamente, Geräte, Diagnostika, Therapieverfahren oder zu epidemiologischen und sozioökonomischen Fragestellungen beitragen. Durch unsere Arbeit wollen wir die Qualität von klinischen Studien fördern und verbessern. Dies erreichen wir durch qualifiziert ausgebildetes Personal, das sich um die Belange der Studienpatienten kümmert. Unser Ziel ist, den Patienten einen Zugang zu neuartigen Therapien und innovativen Forschungsmöglichkeiten zu bieten. Wir sind erfahren in Planung, Organisation und Management pharmazeutischer Phase I, II, III und IV-Studien in den unterschiedlichsten therapeutischen Bereichen der Dermatologie. Ergänzend können wir diagnostische Untersuchungen zur Therapie- und Sicherheitskontrolle während des Studienverlaufs anbieten. Alle Studien werden gemäß der aktuell gültigen GCP (Good Clinical Practice)-Guidelines durchgeführt.
Unser klinisches Studienzentrum besteht aus 3 Bereichen. Der Studienambulanz für Studien aus dem Bereich der allgemeinen Dermatologie, der Dermatoonkologie und Studien zum Thema HIV/AIDS/Geschlechtserkrankungen.
Einrichtung
Die Studienambulanz steht allen Bereichen der Hautklinik der Universitätsklinik Essen zur Verfügung. Die Einrichtung ist…
Erfahrung in klinischen Studien
Unsere Klinik verfügt über langjährige Erfahrung in der Durchführung klinischer Studien und Anwendungsbeobachtungen. Diese Expertise…
Allgemeine Dermatologie-Studien
Studienzentrum allgemeine Dermatologie Wir freuen uns, Patienten im Studienzentrum „allgemeine Dermatologie“ einen möglichst frühzeitig einen…
Dermatoonkologische Studien
Dermatoonkologische Studienambulanz In unserer onkologischen Studienambulanz werden zahlreiche multizentrische klinische Studien zur neoadjuvanten, adjuvanten und…
HIV/HPSTD Studien
HIV/HPSTD-Studienambulanz Sehr geehrter Websitebesucher,in der HIV Ambulanz der Universitätshautklinik Essen bieten wir viele klinische Studien…
Klinische Studien des Wundzentrums -Bereich Dermatologie
Neben der bestmöglichen Diagnostik und Therapie wie diese von Fachgesellschaften und aktuellen Leitlinien empfohlen wird,…
Prof. Dr. med.
Lisa Zimmer
Leitende Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
Prof. Dr. med.
Elisabeth Livingstone
Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
Prof. Dr. med.
Stefan Esser
Leitender Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten
Zusatzbezeichnung: Allergologie
Infektiologisch tätiger Venerologe
Prof. Dr. med.
Joachim Dissemond
Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Allergologie, Sportmedizin
ARCHITECT
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Berufsordnung (BO) / Nicht-interventionell
Zurück
ARCHITECT
Studieninformationen
Studien-Code
UME-ID-11475
UME-ID-11475
Studien-Akronym
ARCHITECT
ARCHITECT
Studientitel
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2015,2016,2017,2018,2019,2021,2022,2023,2025
2015,2016,2017,2018,2019,2021,2022,2023,2025
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Selma Ugurel
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
Registerstudie
Registerstudie
Indikation
Melanom
Melanom
Medizinischer Befund
maligne Melanome
maligne Melanome
BI 1368-0140
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
BI 1368-0140
Studieninformationen
Studien-Code
UME-ID-12223
UME-ID-12223
Studien-Akronym
BI 1368-0140
BI 1368-0140
Studientitel
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025
2025
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Joachim Dissemond
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
Boehringer Ingelheim Pharma GmbH & Co. KG
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Pyoderma gangraenosum (PG)
Pyoderma gangraenosum (PG)
Medizinischer Befund
Pyoderma gangraenosum (PG)
Pyoderma gangraenosum (PG)
D346BC00001 LAVENDER
EudraCT-Nummer: 2021-003698-70
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
D346BC00001 LAVENDER
Studieninformationen
Studien-Code
UME-ID-12163
UME-ID-12163
Studien-Akronym
D346BC00001 LAVENDER
D346BC00001 LAVENDER
Studientitel
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025
EudraCT-Nummer: 2021-003698-70 2024,2025
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
AstraZeneca GmbH
+49 (0)4103 708-0
service.center@astrazeneca.com
Tinsdaler Weg 183 183
22880 Wedel
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
Ausschlusskriterien
* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Studienteilnehmende Höchstalter
70 Jahr(e)
70 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Lupus Erythematodes
Lupus Erythematodes
Medizinischer Befund
Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus
MedDRA Term
Cutaneous lupus erythematosus
Cutaneous lupus erythematosus
DICIT
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Clinical Trial Regulation (CTR) / Interventionell
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Zurück
DICIT
Studieninformationen
Studien-Code
UME-ID-11602
UME-ID-11602
Studien-Akronym
DICIT
DICIT
Studientitel
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Kurzbeschreibung
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025
2024,2025
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Lisa Zimmer
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
Universitätsklinikum Regensburg
Studiendesign
Indikation
Melanom
Melanom
IMA203-301
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
IMA203-301
Studieninformationen
Studien-Code
UME-ID-12467
UME-ID-12467
Studien-Akronym
IMA203-301
IMA203-301
Studientitel
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025,2026
2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immatics US Inc.
Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch
randomisiert, offen, kontrolliert, Multizentrisch
Einschlusskriterien
• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease
• HLA-A*02:01 positive
• Adequate selected organ function per protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma
• Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
• Life expectancy more than 6 months
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.
• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease
• HLA-A*02:01 positive
• Adequate selected organ function per protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma
• Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
• Life expectancy more than 6 months
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.
Ausschlusskriterien
• Primary mucosal or uveal melanoma and melanoma of unknown primary
• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• History of cardiac conditions as per protocol
• Prior allogenic stem cell transplantation or solid organ transplantation
• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs
• Known hypersensitivity to any of the rescue medications
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
• Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Any condition contraindicating leukapheresis
• Pregnant or breastfeeding
• Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)
• Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,
• Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.
• Patients with any active infection or ongoing reactivation of infection
• Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months
• Prior treatment with IMA203
• Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months
• Patients with LDH greater than 2.0-fold ULN
• Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment
• Patients with active brain metastases or leptomeningeal metastases
• Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization
• Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment
• Other protocol defined inclusion/exclusion criteria could apply
• Primary mucosal or uveal melanoma and melanoma of unknown primary
• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• History of cardiac conditions as per protocol
• Prior allogenic stem cell transplantation or solid organ transplantation
• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs
• Known hypersensitivity to any of the rescue medications
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
• Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Any condition contraindicating leukapheresis
• Pregnant or breastfeeding
• Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)
• Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,
• Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.
• Patients with any active infection or ongoing reactivation of infection
• Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months
• Prior treatment with IMA203
• Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months
• Patients with LDH greater than 2.0-fold ULN
• Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment
• Patients with active brain metastases or leptomeningeal metastases
• Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization
• Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment
• Other protocol defined inclusion/exclusion criteria could apply
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanom
Melanom
IMA402-101
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Zurück
IMA402-101
Studieninformationen
Studien-Code
UME-ID-11436
UME-ID-11436
Studien-Akronym
IMA402-101
IMA402-101
Studientitel
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023,2024,2025,2026
2023,2024,2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
immatics biotechnologies GmbH, Tübingen
Studiendesign
Multizentrisch, National
Multizentrisch, National
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
IMC-F106C-301
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
IMC-F106C-301
Studieninformationen
Studien-Code
UME-ID-11454
UME-ID-11454
Studien-Akronym
IMC-F106C-301
IMC-F106C-301
Studientitel
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025,2026
2024,2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immunocore Limited, UK
Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
Ausschlusskriterien
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced melanoma
Advanced melanoma
IMCgp100-203
EudraCT-Nummer: 2022-502732-39-00
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Zurück
IMCgp100-203
Studieninformationen
Studien-Code
UME-ID-11435
UME-ID-11435
Studien-Akronym
IMCgp100-203
IMCgp100-203
Studientitel
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025
EudraCT-Nummer: 2022-502732-39-00 2024,2025
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immunocore Limited, UK
Studiendesign
randomisiert, offen, Multizentrisch, International
randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
Ausschlusskriterien
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced Melanoma
Advanced Melanoma
RP1-104
Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Versus Treatment of Physician's Choice in Patients With Advanced Melanoma That Has Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
RP1-104
Studieninformationen
Studien-Code
UME-ID-12589
UME-ID-12589
Studien-Akronym
RP1-104
RP1-104
Studientitel
Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Versus Treatment of Physician's Choice in Patients With Advanced Melanoma That Has Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Versus Treatment of Physician's Choice in Patients With Advanced Melanoma That Has Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2026
2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Replimune, Inc. USA
Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
Key Inclusion Criteria:
• Male or female who is 12 years of age or older at the time of signed informed consent.
• Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma.
• Confirmed disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence.
1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks
2. Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody are eligible
• Has documented BRAF V600 mutation status. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.
• Has at least 1 measurable and injectable tumor of =1 cm in longest diameter (or shortest diameter for lymph nodes).
• Has adequate hematologic function.
• Has adequate hepatic function.
• Has adequate renal function.
• Prothrombin time (PT) =1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 × ULN
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 for patients 18 years and older or a Lansky performance score (PSc) =80 for patients 12 to 17 years of age.
• Life expectancy of at least 3 months.
• Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of study treatment.
• Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) test within 72 hours before the first dose of study treatment.
Key Inclusion Criteria:
• Male or female who is 12 years of age or older at the time of signed informed consent.
• Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma.
• Confirmed disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence.
1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks
2. Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody are eligible
• Has documented BRAF V600 mutation status. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.
• Has at least 1 measurable and injectable tumor of =1 cm in longest diameter (or shortest diameter for lymph nodes).
• Has adequate hematologic function.
• Has adequate hepatic function.
• Has adequate renal function.
• Prothrombin time (PT) =1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 × ULN
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 for patients 18 years and older or a Lansky performance score (PSc) =80 for patients 12 to 17 years of age.
• Life expectancy of at least 3 months.
• Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of study treatment.
• Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) test within 72 hours before the first dose of study treatment.
Ausschlusskriterien
Key Exclusion Criteria:
• Primary mucosal or uveal melanoma.
• More than 2 lines of systemic therapy for advanced melanoma.
• Known acute or chronic hepatitis.
• Known human immunodeficiency virus (HIV) infection.
• Active significant herpetic infections or prior complications of HSV-1 infection.
• Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to dosing.
• With active significant herpetic infections or prior complications of HSV-1 infection.
• Evidence of spinal cord compression or at high risk of spinal cord compression.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening.
• Serum lactate dehydrogenase (LDH) >2 × ULN.
• Major surgery ?2 weeks prior to starting study drug.
• Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured
• History of significant cardiac disease including myocarditis or congestive heart.
• History of life-threatening toxicity related to prior immune.
• Active, known, or suspected autoimmune disease requiring systemic treatment.
• History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
• Prior oncolytic virus or other therapy given by intratumoral administration.
• Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
• Has received a live vaccine within 28 days prior to the first dose of study treatment.
• Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
• Conditions requiring treatment with immunosuppressive doses (>10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment
Key Exclusion Criteria:
• Primary mucosal or uveal melanoma.
• More than 2 lines of systemic therapy for advanced melanoma.
• Known acute or chronic hepatitis.
• Known human immunodeficiency virus (HIV) infection.
• Active significant herpetic infections or prior complications of HSV-1 infection.
• Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to dosing.
• With active significant herpetic infections or prior complications of HSV-1 infection.
• Evidence of spinal cord compression or at high risk of spinal cord compression.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening.
• Serum lactate dehydrogenase (LDH) >2 × ULN.
• Major surgery ?2 weeks prior to starting study drug.
• Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured
• History of significant cardiac disease including myocarditis or congestive heart.
• History of life-threatening toxicity related to prior immune.
• Active, known, or suspected autoimmune disease requiring systemic treatment.
• History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
• Prior oncolytic virus or other therapy given by intratumoral administration.
• Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
• Has received a live vaccine within 28 days prior to the first dose of study treatment.
• Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
• Conditions requiring treatment with immunosuppressive doses (>10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced Melanoma
Advanced Melanoma
SKABUP
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
SKABUP
Studieninformationen
Studien-Code
UME-ID-12252
UME-ID-12252
Studien-Akronym
SKABUP
SKABUP
Studientitel
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025,2026
2024,2025,2026
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, Multizentrisch
randomisiert, doppelt verblindet, Multizentrisch
Indikation
Skabies
Skabies
V940-012
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
Clinical Trial Regulation (CTR) / Interventionell
Zurück
V940-012
Studieninformationen
Studien-Code
UME-ID-12590
UME-ID-12590
Studien-Akronym
V940-012
V940-012
Studientitel
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025,2026
2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert
randomisiert, doppelt verblindet, kontrolliert
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanom
Melanom